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New treatment option for Locoregionally Advanced Head and Neck Squamous Cell Carcinoma...
Official title Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC
ClinicalTrials.gov ID: NCT05414032
What this study is testing
What is AZD2936?
AZD2936 is an investigational medicine, being studied as a potential treatment for locoregionally advanced head and neck squamous cell carcinoma (la-hnscc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase II, open-label study to assess the efficacy of AZD2936 in terms of molecular residual disease (MRD) clearance and treatment outcome in patients with MRD after definitive treatment for high risk locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). MRD is defined as ctDNA detection in plasma after definitive treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for All Parts
- Age ≥ 18 years at the time of screening or age of consent according to law.
- Written informed consent and any locally required authorization (e.g., data privacy) obtained from the subject prior to performing any...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Weight ≥ 35 kg.
You likely can't join if
- Any of the following would exclude the subject from participation in the study:
- Histological or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the...
- Any unresolved toxicity NCI CTCAE ≥ Grade 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values...
- Evidence of distant metastasis in staging.
- History of allogeneic organ transplantation.
- History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to AZD2936 or any of the...
See the full eligibility criteria
Who can join
- for All Parts
- Age ≥ 18 years at the time of screening or age of consent according to law.
- Written informed consent and any locally required authorization (e.g., data privacy) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Weight ≥ 35 kg.
- Must have a life expectancy of at least 12 weeks.
- Histological or cytological confirmed LA-HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx. Patients with locoregionally advanced unknown head and neck primary but tumor tested to be p16-positive are eligible.
- High-risk HPV negative LA-HNSCC patients (stage III-IVB according to AJCC/UICC 8th Edition) OR high-risk HPV positive LA-HNSCC patients (stage III according to AJCC/UICC 8th Edition).
- Archival tumor formalin-fixed, paraffin-embedded (FFPE) specimens for correlative biomarker studies are required (1 H\&E and 10 unstained 5 microns slides). If surgery is going to be performed after signing consent...
- Patient is a candidate for definitive treatment: either surgery followed by radiation or chemoradiation, OR definitive radiation, OR definitive chemoradiation. for Part C
- Objective radiological tumor response according to CT or MRI at 8-12 weeks after definitive therapy (surgery followed by radiation or chemoradiation, OR definite radiation, OR definite chemoradiation)
- ECOG performance status of 0 or 1 at randomization.
- Tumor must express PD-L1 (CPS ≥1) as determined by the local laboratory using the PD-L1 IHC 22C3 pharmDx assay.
- Detection of ctDNA in plasma samples collected in Part B in either:
- both samples collected at approximately week 5 (4-6) and at week 10 (8-12) OR
- only in the week 10 (8-12) sample NOTE: If ctDNA results at Week 10 are equivocal, a new sample should be collected and analyzed to confirm results within 4 weeks.
- Adequate organ and marrow functions as defined in Table 4.Table 4 (4.1.2-2): Criteria for Adequate Organ and Marrow Function Parameter Value Hematological Hemoglobin ≥ 9 g/dL Absolute neutrophil count ≥ 1,500 µ/L...
- 3 × ULN is allowed in the presence of documented Gilbert's syndrome Alanine transaminase and Aspartate transaminase ≤ 3 × ULN Renal Serum creatinine or Calculated creatinine clearance Serum creatinine \< 1.5 x ULN or...
- Body mass index ≥ 17.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception (see Section 8.1.1 for definition of females of childbearing...
- Nonsterilized male people who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from screening to 4 months after receipt of the final dose of study treatment...
- Objective radiological tumor response according to CT or MRI at 8-12 weeks after definitive therapy (surgery followed by radiation or chemoradiation, OR definitive radiation, OR definitive chemoradiation)
- No detection of ctDNA in plasma samples analysed in the week 10 (8-12) sample collected in Part B.
What rules you out
- Any of the following would exclude the subject from participation in the study:
- Histological or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with p16-negative squamous cell...
- Any unresolved toxicity NCI CTCAE ≥ Grade 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Participants with irreversible toxicity...
- Evidence of distant metastasis in staging.
- History of allogeneic organ transplantation.
- History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to AZD2936 or any of the excipients.
- History of active primary immunodeficiency.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], immune related diverticulitis [prior diverticulitis in the context of...
- Participants with vitiligo or alopecia
- Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy. Participants without active disease in the last 5 years may be included but only after consultation with the Principal Investigator
- Participants with celiac disease controlled by diet alone
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known...
- Patients with a known history of infection with human immunodeficiency virus (positive HIV 1/2 antibodies) are excluded. Testing in patients with no known history or no known risk factors is not required.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, clinically relevant coronary artery disease or history of...
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of study treatment and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤ T2cN0M0 without biochemical recurrence or progression and who in the opinion of the investigator are not deemed to require active...
- Any concurrent anticancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is allowed.
- Prior AZD2936 therapy, anti-PD-1/L1 or TIGIT antibody.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention. The following are exceptions to this criterion (see Section 4.7.1
- Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Participants, if enrolled, should not receive live vaccine whilst receiving study intervention and up to 30 days...
- Participation in another clinical study with an investigational product administered in the last 28 days prior to randomization or concurrent enrollment in another clinical study, unless it is an observational...
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
- For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
- Females who are pregnant, lactating, or intend to become pregnant during their participation in the study.
- people who are involuntarily incarcerated or are unable to willingly provide consent or are unable to comply with the protocol procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.